Biomimetic Oral Appliance Therapy Research Articles

Cone beam computed tomography changes upon oral appliance therapy for adult patients with obstructive sleep apnea: A non-randomized clinical trial.

Obstructive sleep apnea (OSA) is caused by narrowing or obstruction of the airway lumen at single or multiple levels of the airway, starting from the nasal cavity up to the larynx. Oral appliance therapy for the management of OSA is prescribed as an alternative treatment option for patients with mild to moderate OSA who fail to adhere to Continuous Positive Airway Pressure (CPAP) therapy. Treatment with oral appliances addresses the craniofacial deficiencies that cause OSA by providing means to mandibular advancement and palatal expansion, thus opening the airways and potentially preventing airway collapse during sleep. Imaging the upper airway is employed to investigate the narrowing or the obstruction in the airway. Three-dimensional imaging modalities such as cone beam computed tomography (CBCT) allow for detecting obstructions before commencing treatment and for evaluating changes in the upper airway dimensions after treatment. To evaluate the effect of the biomimetic oral appliance therapy (BOAT) device on the airway measurements taken from a CBCT before and after treatment in correlation with the changes in the AHI. A non-randomized clinical trial. About 17 patients with mild-moderate OSA (9 males, 8 females; age, mean [SD]: 45.76 [10.31]) underwent BOAT therapy. Subjects had 2 months of follow-up visits, including examinations for progress and adjustment of the appliances. The mean apnea-hypopnea index (AHI) with no appliance in the mouth before BOAT and after treatment was recorded. The midpalate screw mechanism of the appliance was advanced once per week. The subjects were asked to wear the appliance for 10 to 12 h/d and night. Pre and Post CBCT were taken. Paired T-test was used to analyze the results. The treatment duration was 15.4 ± 6.3 months. Before treatment, at the diagnosis stage, the mean AHI of the sample (n = 17) was 24.0. After treatment, the mean AHI fell by 5% to 22.8% (P = .019), indicating enhanced upper airway functions. Airway measurements from the CBCT were not statistically significant despite improvement in the polysomnographic parameters. CBCT is a valuable tool for airway assessment and the determination of upper airway anatomic risk factors for OSA.

Arch Measurement Changes upon Biomimetic Oral Appliance Therapy for Adults with Obstructive Sleep Apnea

Background: Obstructive Sleep Apnea (OSA) is the most common form of sleep disordered breathing. Patients who arrive at the dental office with a diagnosis of OSA are often treated with a mandibular advancement device (MAD). A biomimetic oral appliance therapy (BOAT) offers an alternative nonsurgical method, which can putatively resolve OSA by combining maxilla-mandibular correction and addressing craniofacial deficiencies. Aim: To determine whether maxilla-mandibular correction changes induced by BOAT produce a more favorable upper airway, which might result in a reduction in the severity of OSA. Methods: Patients who were diagnosed with mild to moderate obstructive sleep apnea (OSA, 9 males, 8 females; age, mean (SD): 45.76(10.31), BMI mean (SD): 33.5(13.43), underwent BOAT therapy. Subjects had 2 months of follow-up visits, including examinations for progress and adjustment of the appliances. The mean apnea-hypopnea index (AHI) with no appliance in the mouth prior to BOAT and after treatment was recorded. The mid-palatal screw mechanism of the appliance was advanced once per week. The subjects were asked to wear the appliance for 10-12 hours/day and night. Paired T-Test was used to analyze the results. Results: The BOAT treatment enhanced upper airway function as the total AHI was significantly lower after treatment (P=0.019). Parameters that were significantly improved by the end of the treatment period included total AHI/Per hour of sleep (p=0.019), NREM-AHI (p=0.019), desaturation index (p=0.041), average SpO2 (p=0.088), and average O2 while in non-REM (p=0.043). Measurements of jaw changes were all statistically significant except lower 6-6 and lower 7-7. Additionally, a strong negative correlation between AHI and jaw changes was shown for upper 6-6 (p=-0.52), upper 7-7 (p=-0.48), and lower 3-3 (p=-0.42). Conclusion: The BOAT provides a useful form of therapy for the resolve of OSA. This study suggests that BOATS may be able to reduce the AHI to within normal limits. Still, long-term follow-up is needed to determine whether these subjects need a maintenance program to retain their initial upper airway improvement.

Biomimetic Oral Appliance Therapy (BOAT): Novel Oral Appliance Treatment for Obstructive Sleep Apnea Administered by Dentists

Biomimetic Oral Appliance Therapy (BOAT): Novel Oral Appliance Treatment for Obstructive Sleep Apnea Administered by Dentists

Berlin and Epworth Surveys to Predict Obstructive Sleep Apnea for Adults on Biomimetic Oral Appliance Therapy: A Nonrandomized Clinical Trial.

Background Two questionnaires (Berlin Questionnaire (BQ) and Epworth Sleepiness Scale (ESS)) are the widely used screening instruments for subjects suffering from sleep disorders. Obstructive sleep apnea (OSA) is the most common form of sleep-disordered breathing. The biomimetic oral appliance therapy (BOAT) offers an alternative nonsurgical method, which can improve symptoms and indices of OSA on objective sleep testing. Aim To describe testing the ability of BQ and EES for prediction of BOAT outcomes during OSA. Methods Seventeen adults (9 males, 8 females; age, mean (SD): 45.76 (10.31), BMI mean (SD): 33.5(13.43)) who underwent an overnight sleep study were diagnosed by a sleep specialist physician. The BQ and EES were recorded before and after BOAT treatment. Subjects with mild-to-moderate OSA had 2 months of follow-up visits and underwent a final overnight sleep study to measure apnea-hypopnea index (AHI). The subjects were asked to wear the appliance for 10–12 hours/day and at night. Findings were analyzed statistically using paired t-tests. Result As per sleep test results, pre-BOAT AHI measures versus post-BOAT AHI measures showed significant improvement. Comparing the BQ before versus after treatment showed that at the pretreatment stage, 66.0% of patients had high-risk score, whereas 34% had low-risk score. After treatment, 66.0% of patient had low-risk scores, whereas 34% had high-risk scores. As for the ESS, treatment resulted in significant reduction of total score from 10.43 ± 6.32 to 5.00 ± 5.20 (P < 0.01, paired t-test). Finally, there was a mild negative correlation between AHI and each of the BQ and ESS scores that was not statistically significant (r = −0.420, N = 26, P > 0.05, and r = −0.41, N = 26, P > 0.05, respectively). Conclusion The BOAT device may provide a useful form of therapy to improve OSA-related PSG parameters such as AHI. Both BQ and ESS were predictive to improvements detected by the sleep study during BOAT device use.

Changes in pneumatization of the maxillary air sinuses in Korean adults following biomimetic oral appliance therapy.

ObjectiveFor the treatment of obstructive sleep apnea in adults, mandibular advancement devices (MADs) are often used. Since adults with a prognathic mandibular phenotype are at risk of developing an unfavorable facial profile, midfacial development using biomimetic oral appliance therapy might provide a suitable alternative. However, the effect of this procedure on the maxillary air sinuses is unknown; therefore, changes in sinus pneumatization were investigated in this study.MethodsAfter obtaining informed consent, 16 consecutive Korean adults with midfacial hypoplasia had 3D cone-beam (CB) CT scans taken, and biomimetic upper appliances (DNA appliance®, Vivos Therapeutics, Inc., USA) were constructed.All subjects were instructed to wear the device 12–16 h/day. Each month, examination for the progress of midfacial development was recorded. Post-treatment, a follow-up 3D CBCT scan was undertaken with no device in the patient's mouth. Pre- and post-treatment linear and volumetric measurements were obtained using appropriate software, and compared statistically using t-tests.ResultsThe mean age of the sample was 25.0 yrs ± 8.7. The mean treatment time was 15.5 mths ± 5.2. Post-treatment, the transpalatal bone width increased from 35.3 mm ± 3.0 to 38.5 mm ± 2.0 (P < 0.001); the maxillary air sinus volume on the left side increased from 18.8 cm3 ± 6.5 to 20.0 cm3 ± 6.0 (P < 0.05), and from 18.5 cm3 ± 5.7 to 19.7 cm3 ± 5.8 (P < 0.05) on the right side.ConclusionsBiomimetic oral appliance therapy may be able to increase the maxillary air sinus volume in adults. In view of these preliminary findings, further studies on the effect of enhanced pneumatization on paranasal sinus function and sleep parameters are warranted.

3D craniofacial and upper airway changes after biomimetic oral appliance therapy in Korean adults

3D craniofacial and upper airway changes after biomimetic oral appliance therapy in Korean adults

Upper oropharyngeal airway changes in Korean adults following biomimetic oral appliance therapy

Upper oropharyngeal airway changes in Korean adults following biomimetic oral appliance therapy

Changes is sleep parameters following short-term biomimetic oral appliance therapy for obstructive sleep apnea in adults

Changes is sleep parameters following short-term biomimetic oral appliance therapy for obstructive sleep apnea in adults

0553 Non-Surgical Osseous Remodeling and Myofunctional Therapy for Skeletal class III Malocclusion with Severe OSA

Obstructive Sleep Apnea (OSA), is a common sleep-disorder; causes of OSA vary, including decreased pharyngeal muscle tone, craniofacial obesity, and craniofacial deficiencies amongst others. Current treatments are continuous positive airway pressure therapy (CPAP), as well as MRA and MMA surgery. This study tests that if a non-surgical biomimetic oral appliance therapy (BOAT) DNA® System is used in combination with a sagittal expander and Myofunctional therapy for soft tissue remodeling and brain remapping; then AHI can be reduced in addition to oxygen desaturation. This study includes two class III adults: male A (45 years) with 65% oxygen desaturation and male B (45 years) with 78% oxygen desaturation. The cases were treated with FDA-cleared DNA Appliance© for osseous remodeling, and Myofunctional therapy for 6 months, followed by sagittal expansion. Before treatment the craniofacial region was imaged using 3D cone-beam CT scans. After 9 months of treatment, the apnea hypopnea index (AHI) was reassessed, without any appliance, by home sleep study (HST). The upper airway volume was reassessed with another 3D cone-beam CT scan and upper airway analysis. This process was repeated after the sagittal expander. For both cases, the mean AHI decreased from severe to mild, while the upper airway volume (from the posterior nasal spine to the epiglottis) increased by 15% and oxygen desaturation decreased. This preliminary study suggests that a decrease in AHI and oxygen desaturation may be associated with combined non-surgical osseous upper airway remodeling, a sagittal expander; and Myofunctional therapy, for soft tissue remodeling and brain pattern remapping, for skeletal class III with severe OSA in adults with craniofacial deficiencies. N/A.

Biomimetic Oral Appliance Therapy in Adults with Mild to Moderate Obstructive Sleep Apnea Using Combined Maxillo-Mandibular Correction

Although mandibular advancement devices (MADs) are utilized for the management of mild to moderate OSA, there are concerns about temporo-mandibular joint (TMJ) issues. Biomimetic oral appliance therapy (BOAT) differs from MADs as it aims to achieve midfacial redevelopment in combination with mandibular repositioning. In this study, we tested the hypothesis that mild to moderate cases of OSA can be addressed with combined maxillo-mandibular correction using BOAT.

0636 NON-SURGICAL, UPPER AIRWAY REMODELING FOR UARS

Upper airway resistance syndrome has become a prevalent form of sleep-disordered breathing. The causes for UARS include decreased pharyngeal muscle tone, and craniofacial deficiencies amongst others. Current methods used to manage UARS - include no standard medical treatment; continuous positive airway pressure (CPAP) therapy and/or mandibular advancement appliances have been used without any results. Therefore, this study is to test the hypothesis that a biomimetic oral appliance therapy (BOAT) can be used followed by a DNA appliance, with a forward facial head-gear mask. This pilot study included two adults: 2 females, 29 years and 32 years, (mean age 31yrs.) diagnosed with UARS to mild OSA who were treated with FDA-cleared BOAT (MRNA appliance®) followed with a forward facial mask for osseous remodeling. Prior to treatment the craniofacial region was imaged using 3D cone-beam CT scans. After 9 to 15 months of treatment, the upper airway volume was reassessd with 3D cone-beam CT scans and upper airway analysis. For case 1, the upper airway volume (from the posterior nasal spine to the epiglottis) prior to treatment was 9.28cm 3 and increased to 16cm 3, representing a 29% increase in upper airway volume. For case 2, upper airway volume increased from 16.7cm 3 prior to treatment to 20.5cm 3 post-treatment, showing a 12.5% increase in upper airway volume. By subjective questionnaires of before and after, the patients have improved immensely. This preliminary study indisputably suggests that increases in 3D airway may be associated with non-surgical upper airway remodeling for UARS in adults with craniofacial deficiencies. None

Changes in 3D nasal cavity volume after biomimetic oral appliance therapy in adults

Objective: In this study, the authors investigated 3D changes in nasal volume, to test the hypothesis that nasal cavity volume can be changed in adults.Methods: After obtaining informed consent, the authors undertook 3D cone-beam computerized axial tomographic (CBCT) scans of 11 consecutive adults (mean age: 37.9 years), before and after biomimetic oral appliance therapy (BOAT). The mean treatment time was 18.462.5 months. Volumetric reconstruction of the nasal cavity was undertaken, and the nasal volume was calculated in all cases. The findings were subjected to statistical analysis, using paired t-tests.Results: The mean nasal cavity volume was 41.9612.0 cm3 before treatment. After BOAT, the mean volume increased to 44.0612.7 cm3 (P50.022).Conclusions: These data support the notion that nasal cavity volume can be changed in adults. Use of BOAT might improve continuous positive airway pressure (CPAP) compliance in adults diagnosed with obstructive sleep apnea (OSA), by increasing the nasal cavity volume and decreasing nasal airflow resistance.

A Novel Combined Protocol for the Resolution of Severe Obstructive Sleep Apnea

A 27-year-old woman was referred to our office for a dental assessment regarding temporomandibular joint pain. On initial screening, she was found to be at high risk for obstructive sleep apnea, and subsequently underwent polysomnography, which revealed an apnea-hypopnea index of 118 hr-1. Her condition was initially controlled with continuous positive airway pressure therapy, which she did not tolerate well. Therefore, treatment proceeded with biomimetic oral appliance therapy. After 10 months of combined continuous positive airway pressure therapy and biomimetic oral appliance therapy, the apnea-hypopnea index fell to 1 hr-1 and obstructive sleep apnea could not be observed with or without the appliances in situ. We conclude that combined continuous positive airway pressure therapy and biomimetic oral appliance therapy might represent a potential cure for severe cases of obstructive sleep apnea in certain patients.

Facial enhancement using biomimetic oral appliance therapy in adults

Facial enhancement using biomimetic oral appliance therapy in adults

Effects of biomimetic oral appliance therapy in adults with obstructive sleep apnea

Effects of biomimetic oral appliance therapy in adults with obstructive sleep apnea

Biomimetic Oral Appliance Therapy in Adults with Severe Obstructive Sleep Apnea

Introduction: While Continuous Positive Airway Pressure (CPAP) is widely used to manage Obstructive Sleep Apnea (OSA), compliance can be problematic in some cases. These patients are often referred for Mandibular Advancement Devices (MADs) but there is less evidence of their efficacy in severe cases. We investigated the use of biomimetic oral appliance therapy (BOAT) to test the hypothesis that severe cases of OSA can be addressed using BOAT. Materials and Methods: 15 consecutive adults aged >21 yrs with severe OSA that were unable to comply with CPAP according to a medical physician were treated using BOAT with or without primary mandibular advancement by a dentist with advanced training in dental sleep medicine. The mean Apnea-Hypopnea Index (AHI) of the sample was calculated prior to and after BOAT with no appliance in the mouth during the sleep studies. The findings were subjected to statistical analysis, using paired t-tests. Results: Prior to treatment the mean AHI of the study sample was 45.9 hr-1 ± 10.5. A follow-up sleep study at 9.7 mos. ± 1.9 showed a 64% decrease in AHI to a mean value of 16.5 hr-1 ± 8.8 after BOAT (p<0.01) with no appliance in the mouth during the post-treatment sleep studies. Results for those without primary mandibular advancement were: 46.6 hr-1 ± 12.9 pre-treatment vs. 13.9 hr-1 ± 10.5 after BOAT (p<0.01); and for those treated with initial mandibular advancement: 45.2 hr-1 ± 8 pre-treatment vs. 19.5 hr-1 ± 6 after BOAT (p<0.01). Conclusions: BOAT may be a useful method of managing severe cases of OSA in adults, and represents an alternative to CPAP and MADs. However, long-term follow up is needed to reach more definitive conclusions on these initial findings.

Resolution of Sleep Bruxism using Biomimetic Oral Appliance Therapy: A Case Report

Background: Evidence suggests that sleep bruxism is centrally regulated, and that the highest risk factor associated with sleep bruxism is obstructive sleep apnea. Current treatments for sleep bruxism include dental nightguards or occlusal splints, which are often provided without upper airway or sleep assessments. Methods: In this case report, we used biomimetic oral appliance therapy to address sleep bruxism by redeveloping the maxilla and repositioning the mandible in a 17 yr. old, female patient. Results: The upper airway volume increased by 313% (from 7.7 cm3 to 24.1 cm3) and the minimum upper airway cross-sectional area increased by 230% from (120 mm2 to 276.5 mm2), which improved both sleep bruxism and orthodontic relapse. Conclusion: We conclude that dentists and orthodontists can help in the recognition and treatment of both sleep bruxism and malocclusion, thereby preventing systemic co-morbidities associated with obstructive sleep apnea.

Changes in 3D Midfacial Parameters after Biomimetic Oral Appliance Therapy in Adults

Changes in 3D Midfacial Parameters after Biomimetic Oral Appliance Therapy in Adults

Changes in 3D Midfacial Parameters after Biomimetic Oral Appliance Therapy in Adults

Background/objectives/aims: Controversy exists regarding maxillary bone changes in nongrowing adults. However, previous studies have relied on two-dimensional (2D) cephalo metric analyses, which may be unable to capture three-dimen sional (3D) pheno mena. In this study, we investigated 2D and 3D parameters to test the null hypothesis that maxillary bone volume cannot be changed in nongrowing adults that had been diagnosed with mid facial underdevelopment. Methods: After obtaining informed consent, we undertook 3D cone beam computed tomography scans of 11 consecutive, adult patients prior to and after biomimetic, oral appliance therapy. The mean treatment time was 18.4 months ± 2.5 using the DNA appliance® system. The intramolar width and 3D volume of the midface was calculated prior to and after the mid facial redevelopment protocol. The findings were subjected to statistical analysis. Results: The mean intramolar increased from 33.5 mm ± 3.4 prior to treatment to 35.8 mm ± 2.9 after appliance therapy (p = 0.0003). Similarly, the mean midfacial bone volume was 17.4 cm3 ± 3.9 prior to treatment and increased to 19.1 cm3 ± 2.6 after appliance therapy (p = 0.0091). Conclusion: These data support the notion that maxillary bone width and volume can be changed in nongrowing adults. Furthermore, midfacial redevelopment may provide a potentially-use ful method of managing adults diagnosed with obstructive sleep apnea, using biomimetic, oral appliances.